Kornimate/medical-research-clean huggingface dataset:
mogamulizumab q4week dosing in participants with r/r ctcl

Conditions: Cutaneous T-Cell Lymphoma, Relapsed; Cutaneous T-Cell Lymphoma Refractory

Summary: this is an open-label, multicenter, phase 2 study to evaluate the safety and tolerability of mogamulizumab given q4w following initial weekly induction in adult participants with relapsed/refractory mf and ss subtypes of ctcl. the study is composed of a 28-day screening period during which participants are screened for entry into this study, followed by a treatment period of up to 2 years from cycle 1 day 1.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of mf or ss * stage ib, ii-a, ii-b, iii, or iv; * participants who have failed at least one prior course of systemic therapy (e.g., interferon, bexarotene, photopheresis, anti-neoplastic chemotherapy). psoralen plus ultraviolet light therapy (puva) is not considered a systemic therapy. exclusion criteria: * current evidence of large cell transformation; * prior treatment with mogamulizumab; * history of allogeneic transplant.
melatonin for post operative delirium prevention in elderly patients

Conditions: Delirium in Old Age

Summary: the present study will evaluate the role of melatonin prophylaxis in delirium prevention in elderly patients undergoing colorectal procedures.

this study is a prospective randomised double-blind placebo-controlled trial. patients who meet the criteria for inclusion/exclusion will be evaluated. melatonin tablets will be administered as a premedication to patients in the melatonin group. patients in the control group will be given placebo tablets as a premedication. fentanyl 1ug/kg and propofol 1-2 mg/kg will be used to induce anaesthesia. atracurium 0.5 mg/kg will be used for the facilitation of endotracheal intubation. isoflurane will be used to maintain anaesthesia and the depth of anaesthesia will be adjusted by a bispectral index monitor. postoperatively, the patients will be monitored for the development of delirium.

Eligibility criteria:
inclusion criteria: * american society of anaesthesiologists (asa) i to iii physical status * elective colorectal procedures exclusion criteria: * allergy to the research drugs, * patients who have vision or hearing impairment * history of cerebral disorders * uncorrected acid-base, fluid, and electrolyte abnormalities * history of central nervous system function affecting drugs. * chronic sedative-hypnotic administration at least one month prior to surgery * alcohol abuse * patients with recorded preoperative nursing delirium screening score ≥ 2.
acute dyspnea after use of non-invasive ventilation in copd and emphysema (deventilation syndrome)

Conditions: Obstructive Chronic Bronchitis

Summary: acute dyspnea after use of non-invasive ventilation (niv) is a common phenomenon in patients with copd and emphysema. this trial aims to document incidence and severity of augmented dyspnea in patients with long term niv therapy. these findings may help in understanding the pathomechanisms that lead to post-niv dyspnea and thus give way to potential therapy schemes.

non-invasive ventilation (niv) is a widespread therapy option for patients with hypercapnic failure due to copd and emphysema. augmented dyspnea after use of niv is commonly found and leads not only to high patient discomfort, but can also be associated with acute respiratory failure. this monocentric obervation trial includes patients with copd iii°-iv° (gold) and emphysema and an established long term niv therapy. during their routine inpatient follow-up, we will extend the routine examinations, focussing on the vulnerable first hour after the nocturnal use of niv. this includes monitoring of breath rate, heart rate, pulsoxymetry, trancutaneous co2, blood pressure and capillary blood gas analysis. sonographic measurement of diaphragm movement and thickness will be complemented. subjective dyspnea will be documented by use of the borg scale. by collecting this data, we hope to understand the pathomechanisms causing augmented dyspnea after niv and thus provide information for therapeutical concepts to prevent it.

Eligibility criteria:
inclusion criteria: * males and females with stabile copd, last exacerbation over one month, * gold iii to iv * regular use of noninvasive ventilation, more than four hours per day for more than one year * signed declaration of consent * sufficient language capabilities, german exclusion criteria: * acute exacerbation in the past four weeks * acute pulmonary embolus * haemoptysis * severe neurological disease * severe cardiological disease * haemodynamic instability * new hypoxia or worsening of hypercapnia more than twenty percent of usual rate * acute pneumothorax * other instable situation, for example intraabdominal bleedings * drug or alcohol dependency * regular intake of morphium * adiposity bmi over 35
study of hypoxia measured in f-miso pet/scan and mri in patients with squamous cells carcinoma

Conditions: Squamous Cell Carcinoma of the Oropharynx

Summary: hypoxia imaging has not been studied extensively by combining pet and mri data. few studies performed the double imaging and none associated anatomopathology with it . this study will use a rigorous methodology through the production of pet/mri images at the same time by transferring the patient directly from pet to mri. in addition, the population, unlike other studies, will include preoperative patients with 24-hour surgery for hypoxia imaging by obtaining additional data through specific immunohistochemical analysis of hypoxia.


Eligibility criteria:
inclusion criteria: * patient with squamous cells carcinoma of oropharynx * age superior to 10 years old * male or female * measurable target according recist criteria exclusion criteria: * -other histologic cancer than squamous cells carcinoma of oropharynx * no measurable target * presence of metastasis

Keywords: f-miso pet scan magnetic resonance imaging immunohistochemistry head and neck cancer
evaluation of effectiveness of two dosing regimens of fostamatinib compared to placebo in patients with rheumatoid arthritis (ra) who are taking disease modifying anti-rheumatic drug (dmard) but not responding.

Conditions: Rheumatoid Arthritis

Summary: the purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (ra) who are taking disease modifying anti-rheumatic drug (dmard) but not responding. the study will last for 1 year.

sub-study: full title: optional genetic research date: 18 june 2010 version: 1 objectives: to collect and store, with appropriate consent ,dna samples for future exploratory research into genes/genetic variation that may influence response (ie, absorption, distribution, metabolism and excretion, safety, tolerability and efficacy) to fostamatinib disodium and/or methotrexate; and/or susceptibility to, progression of and prognosis of ra

Eligibility criteria:
inclusion criteria: * active rheumatoid arthritis (ra) diagnosed after the age of 16 * treatment with one the following disease modifying anti-rheumatic drug: methotrexate, sulfasalazine, hydroxychloroquine or chloroquine * 4 or more swollen joints and 4 or more tender/painful joints (from 28 joint count)and either erythrocyte sedimentation rate (esr) blood result of 28mm/h or more, or c-reactive protein (crp) blood result of 10mg/l or more * at least one of the following: documented history of positive rheumatoid factor (blood test), current presence of rheumatoid factor (blood test), radiographic erosion within 12 months prior to study enrolment, presence of serum anti-cyclic citrullinated peptide antibodies (blood test) exclusion criteria: * females who are pregnant or breast feeding * poorly controlled hypertension * liver disease or significant liver function test abnormalities * certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders * recent or significant cardiovascular disease * significant active or recent infection including tuberculosis * previous failure to respond to a tnf alpha antagonist, anakinra or previous treatment with other biological agent * severe renal impairment * neutropenia

Keywords: rheumatoid arthritis
duke covid-19 shared data and specimen repository

Conditions: COVID-19

Summary: the purpose of this data repository is to provide a secure and centralized storage location and resource for the collection of essential data and medical specimens, across covid-19 related protocols at duke.

the aim of this data repository is to provide a secure and centralized storage location and resource for the collection of core variables of interest, as well as the retaining of relevant patient samples, across covid-19 related protocols at duke. the core data variables were in-part selected to specifically match those agreed upon by academic medical centers across the u.s., with the intention of aiding the efficiency and effectiveness of de-identified data reuse for population-level research. an additional benefit is that centralized, shared data storage of demographic and longitudinal variables will reduce subject burden, as many questions will now only need to be asked once, rather than each time a given subject joins another covid-19 related study at duke. this shared data and bio-repository project will house all the core data for all patients with covid-19 (or suspected cases), as well as individual participants icfs for all other participating covid-19 studies enrolling duke patients. each participating study will have its own separate irb approved protocol. samples may be either collected specifically by the protocol, or include left-over clinical samples from the testing and treatment of patients with covid-19 at duke.

Eligibility criteria:
subjects will be included in this data repository if they meet the enrollment criteria of any linked/participating irb-approved protocol, or if they are not enrolled in another covid-related study but meet one of the following inclusion criteria: 1. suspected novel coronavirus (ncov) infection (person under investigation) and/or 2. laboratory proven acute novel coronavirus (ncov) infection and/or 3. primary admitting diagnosis of ncov infection studies will include: * any covid-19 clinical research studies recruiting duke patients * excludes: protocols sharing non-consented ehr data with national/international repositories and studies that are recruiting community participants

Keywords: data specimen repository
perioperative cognitive training in thoracic surgery

Conditions: Pain, Postoperative; Cognitive Function Abnormal; Lung Cancer

Summary: more than 30% of patients undergoing thoracic surgical procedures develop persistent post-surgical pain (ppsp), which results in impaired functioning, diminished quality of life, and increased risk of chronic opioid use. the proposed project aims to determine whether a prospective, randomized, controlled study of smartphone-based perioperative cognitive flexibility training will reduce the incidence of ppsp in high-risk individuals undergoing thoracic surgery.


Eligibility criteria:
inclusion criteria: * adults age 18 to 75 undergoing thoracic surgery * access to an active email account * score \<50th percentile on color word matching stroop test (cwmst) normalized t-score exclusion criteria: * unable to complete cognitive testing * color blindness assessed via self-report * participants who do not speak or read english the inclusion criteria for the observational cohort will be the same, with the exception of score ≥50th percentile on color word matching stroop test (cwmst) normalized t-score.
metabolic effects of high-amylose wheat-based rusks.

Conditions: Hyperglycemia

Summary: amylose-amylopectin ratio may influence the rate of starch digestion. this randomized controlled study evaluated the postprandial metabolic effects of amylose-rich- wheat- based rusks in overweight subjects.


Eligibility criteria:
inclusion criteria: * overweight/obese; * 30-60 years. exclusion criteria: * age \ 60 years; * fasting triglycerides ≥400 mg/dl; * fasting cholesterol \>270 mg/dl; * cardiovascular events (myocardial infarction or stroke) during the 6 months prior to the study; * established diabetes mellitus or any chronic disease; * renal and liver failure (creatinine \>1.7 mg/dl and transaminases \>2 times than normal values, respectively); * anaemia (hb \<12 g /dl); * any chronic disease.
improvement of facial nerve monitoring in parotid surgery by sugammadex

Conditions: Injury to Nerve During Surgery

Summary: to investigate the effectiveness of rapid reversal of rocuronium-induced neuromuscular block by sugammadex during ionm of facial nerve during parotid surgery

intraoperative neuromonitoring (ionm) of facial nerve has been applied in identifying and preserving facial nerve during parotid surgery. in this setting, even a single dose of nondepolarizing muscle relaxant may lead to delayed and weakened electromyography (emg) signal in facial nerve monitoring during parotid surgery. the aim of this study was to investigate the effectiveness of rapid reversal of rocuronium-induced neuromuscular block by sugammadex during ionm of facial nerve during parotid surgery

Eligibility criteria:
inclusion criteria: * undergoing parotid surgery exclusion criteria: * facial nerve injury, renal failure, liver cirrhosis, neuromuscular disease
multi-site study of rapid diagnostic syphilis assays

Conditions: Syphilis

Summary: the performance of an investigational immunochromatographic strip (ics) test for the diagnosis of syphilis is compared with the abbott laboratories determine ics test. the study population consists of patients with and without syphilis presenting to sexually transmitted disease clinics in five cities in the united states. specimens include finger-stick whole blood (investigational test only) and whole blood, plasma, and serum by venipuncture.


Eligibility criteria:
inclusion criteria: * consecutive patients exclusion criteria: * less than age 18 years

Keywords: diagnosis
change of renal function and bone mineral density in chb patients switch from tdf to taf vs. maintaining tdf

Conditions: Chronic Hepatitis B

Summary: in chronic hepatitis b (chb) patients receiving long-term sequential neucleos(t)ides(nas), majority of these chb patients experienced drug resistance and switched to tenofovir disoproxil fumaratate(tdf). however, some of patients on long term tdf experienced impairment of renal function and bone mineral density. after tenofovir alafenamide(taf) was in clinical practice, these group of patients got an clinical option to switch from tdf to taf. the investigators designed a prospective cohort study to evaluate the real life effectiveness and safety in participants with chronic hbv infection switch from tdf to taf vs. maintaining on tdf.

tenofovir disoproxil fumarate(tdf) have been associated with renal toxicity and reduced bone mineral density. tenofovir alafenamide(taf) is a novel tenofovir prodrug that reduces tenofovir plasma concentrations by 90%, thereby decreasing off-target side-effects. the investigators aimed to assess whether efficacy, safety, and tolerability were non-inferior in participants switched to taf versus in those remaining on tdf. this is a prospective clinical study.

Eligibility criteria:
inclusion criteria: 1. chronic hepatitis b, 2. antiviral experienced, 3. currently on long term tdf anti-hbv treatment, 4. hbv dna \< 6 log iu/ml (llod) 5. able to sign the consent form of anticipating in the study exclusion criteria: 1. co-infected with hcv, hiv or other viral hepatitis, 2. diagnosis of hcc

Keywords: chronic hepatitis b efficacy, safety, and tolerability tenofovir alafenamide
study to evaluate the performance of aquacel® extra™ in venous leg ulcers

Conditions: Leg Ulcer

Summary: based upon the in-vitro data aquacel® extra™ achieves a 39% increase in absorbency. as such it is anticipated that through improved exudate management a longer wear time will be achieved in the aquacel® extra™ group compared to aquacel® in the management of chronic wounds such as venous leg ulcers.


Eligibility criteria:
inclusion criteria: * subjects over 18 years, willing and able to provide written informed consent. * subjects who have an ankle to brachial pressure index (abpi) of 0.8 or greater * subjects who have a venous leg ulcer (i.e. ceap classification of c6 1) with duration less than 24 months * subjects whose ulcer is no smaller than 2cms in any one direction * subjects whose ulcer is no greater than 11cm in any one direction (measured by longest length and widest width) * subjects' whose index leg ulcer has a moderate to heavy level of exudate. * subjects whose index (study) leg is currently being treated with compression therapy and whose leg oedema is under control * subjects who are willing and able to comply with the requirements of the clinical investigation plan in relation to the dressing/compression regime and the ability to attend dressing changes as required. exclusion criteria: * subjects with a history of skin sensitivity to any of the components of the study dressings (aquacel® extra™, aquacel®, \& duoderm™ extra thin) * subjects whose wounds are considered clinically infected at baseline * subjects whose leg ulcers are malignant, or who have had recent deep venous thrombosis or venous surgery within the last 3 months. * subjects who have progressive neoplastic lesion treated by radiotherapy or chemotherapy, or on-going treatment with immunosuppressive agents * subjects exhibiting any other medical condition which, according to the investigator, justifies the subject's exclusion from the study * subjects who have participated in a clinical study within the past month.
effect of growth hormone on early brain development in girls with turner syndrome

Conditions: Turner Syndrome

Summary: the purpose of this research study is to learn about brain development in very young girls with turner syndrome (ts) and the effect that growth hormone (gh) therapy has on early brain development.

studies in older children and adults have found that iq (intelligence quotient) in individuals with turner syndrome (ts) and the general population are similar. however, many individuals with ts have a nonverbal learning disability which may cause problems with imagining and working with objects in space (for example: building blocks, working puzzles, copying designs, driving a car) as well as problems in planning, paying attention, and getting along with people their own age. studies of brain structure have found changes in the size and function of specific areas of the brain that are involved in these nonverbal processes. however, there are no data published on brain structure or function in girls with turner syndrome in the first few years of life when brains are learning and growing most rapidly. in a recent study, very young, short girls with turner syndrome (ts)(averaging 2 years in age) were treated with growth hormone (gh) and almost reached an average height after 2 years. the risks of gh for the young girls in that study appeared to be the same as those for older girls. therefore, it is now recommended that gh therapy be considered as soon as a child with ts has growth failure. growth failure often occurs during infancy; therefore, more children with ts are now receiving gh therapy as young as 12 months of age. in this study, the investigators wish to start understanding what effect gh has on learning and brain growth when given between the ages of 12 and 24 months. in this study, the girls with ts will have developmental studies, a physical examination, magnetic resonance imaging (mri), and blood drawn at one and two years of age. some of the girls in this study will receive gh from 12 until 24 months of life, while others will not. brain growth and development will be compared between those who have been treated with gh and those who have not. this is a pilot study in which the investigators will gather data to design a larger study that can answer these questions.

Eligibility criteria:
inclusion criteria: * diagnosis of turner syndrome * less than the 50th percentile for length for the general female population exclusion criteria: * prior growth hormone (gh) therapy * diabetes * allergy to metacresol (a preservative in the gh liquid that is injected) * contraindications for magnetic resonance imaging (mri) (such as metal in the body) * part of a y chromosome in child's karyotype * parent/guardian is not willing for child to be randomized to be in the treatment group (receives growth hormone injections for one year) or the control group (receives no growth hormone during the study) * parent/guardian is not willing for child to have some of her developmental testing digitally recorded for scoring

Keywords: turner syndrome growth hormone brain development
fat reduction induced by magnetic device - waist circumference evaluation

Conditions: Fat Burn

Summary: the study is a prospective multi-center open-label single-arm study. the subjects will be enrolled and assigned into a single study group. subjects will be required to complete four (4) treatment visits and four follow-up visits, 1 month, 3, 6 and 12 months after the final treatment. at the baseline visit photographs of the abdomen will be taken. in addition, patient umbilical circumference will be measured and the subject's weight will be recorded. in addition, at the last therapy visit, subjects will receive subject satisfaction and therapy comfort questionnaires to fill in. safety measures will include documentation of adverse events (ae) including subject's experience of pain or discomfort after the procedure. following each treatment administration and at the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment. post-procedure evaluation (follow-up visits) will be conducted 1 month, 3, 6 and 12 months after the final treatment. umbilical circumference and weight measure will be conducted at every follow-up visit. also, subject's satisfaction will be noted. during the first (1 month), third (6 months) and last (12 months) follow-up visits, photographs of abdomen will be taken.


Eligibility criteria:
inclusion criteria: * adult subjects of both genders with unwanted abdominal fat and expressing interest in treatment * age ≥ 22 years * voluntarily signed informed consent form * bmi ≤ 30 kg/m2 exclusion criteria: * cardiac pacemakers * electronic implants * pulmonary insufficiency * metal implants * drug pumps * haemorrhagic conditions * anticoagulation therapy * heart disorders * malignant tumor * fever * pregnancy * breastfeeding * following recent surgical procedures when muscle contraction may disrupt the healing process * application over menstruating uterus * application over areas of the skin which lack normal sensation * scars, open lesions and wounds at the treatment area * unrepaired abdominal hernia

Keywords: abdominal fat